Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Atomoxetine hydrochloride
Genus Pharmaceuticals Ltd
N06BA09
Atomoxetine hydrochloride
25mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04040000; GTIN: 5011309006018
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ATOMOXETINE 10MG HARD CAPSULES ATOMOXETINE 18MG HARD CAPSULES ATOMOXETINE 25MG HARD CAPSULES ATOMOXETINE 40MG HARD CAPSULES ATOMOXETINE 60MG HARD CAPSULES ATOMOXETINE 80MG HARD CAPSULES ATOMOXETINE 100MG HARD CAPSULES Atomoxetine (as hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. The full name of this medicine is Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules but within the leaflet it will be referred to as Atomoxetine Capsules. WHAT IS IN THIS LEAFLET 1. What Atomoxetine Capsules are and what they are used for 2. What you need to know before you take Atomoxetine Capsules 3. How to take Atomoxetine Capsules 4. Possible side effects 5. How to store Atomoxetine Capsules 6. Contents of the pack and other information 1. WHAT ATOMOXETINE CAPSULES ARE AND WHAT THEY ARE USED FOR WHAT IT IS USED FOR Atomoxetine Capsules contain atomoxetine and is used to treat attention-deficit and hyperactivity disorder (ADHD). It is used - in children over six years of age - in young people - in adults It is used only as a part of the total treatment of the disease which also requires treatments which do not involve medicines, such as counselling and behavioural therapy. It is not for use as a treatment for ADHD in children under 6 years of age as it is not known if the drug works or is safe in this age group . In adults, Atomoxetine Capsules are used to treat ADHD when the symptoms are very troublesome and affect your work or social life and when you have had sym Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atomoxetine 25mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains atomoxetine hydrochloride equivalent to 25 mg of atomoxetine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule Atomoxetine 25 mg capsules: hard capsule, size 3 (15.9 mm x 5.82 mm), opaque blue (cap) and opaque white (body), imprinted with “A925” in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atomoxetine Capsules is indicated for the treatment of Attention- Deficit/Hyperactivity Disorder (ADHD) in children of 6 years and older, in adolescents and in adults as part of a comprehensive treatment programme. Treatment must be initiated by a specialist in the treatment of ADHD, such as a paediatrician, child/adolescent psychiatrist, or psychiatrist. Diagnosis should be made according to current DSM criteria or the guidelines in ICD. In adults, the presence of symptoms of ADHD that were pre-existing in childhood should be confirmed. Third-party corroboration is desirable and Atomoxetine Capsules should not be initiated when the verification of childhood ADHD symptoms is uncertain. Diagnosis cannot be made solely on the presence of one or more symptoms of ADHD. Based on clinical judgment, patients should have ADHD of at least moderate severity as indicated by at least moderate functional impairment in 2 or more settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual’s life. Additional information for the safe use of this product A comprehensive treatment programme typically includes psychological, educational and social measures and is aimed at stabilising patients with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal EEG. Learning may or may not be impaired. Les hele dokumentet